AneuFix / AneuFill Polymer
The AneuFix / AneuFill polymer mix is tuned to cure in several minutes to give the physician ample time to fill the void in a controlled fashion, be it the endoleak or the complete aneurysm sac, while at the end of the filling procedure the time needed for the patient to remain still on the operating table is kept short.
After curing, an elastic in-situ implant is formed completely filling the void and all irregularities of the leak or sac. All inflow and outflow vessels are blocked for the first millimeters. The typical characteristics of siloxane polymer means the implant has a high elasticity of more than 100%, while the additives in the siloxane provide for a strong and durable product. Due to the softness and elasticity of the material, any potential movement of the EVAR endograft and/or sac is not compromised.
AneuFix / AneuFill is a 2-component siloxane polymer using a proprietary set of additives to create special characteristics that make this product uniquely suitable for treatment of aortic aneurysms.
In case of Endoleak repairs, the leak that needs to be stopped typically has blood flowing in and out of the leak at a high flowrate of up to 100 ml/min. Injecting a fluid in such an flow stream has a high risk of unwanted displacement or embolization of the injected material and blocking blood vessels more distally. To prevent this, either the flow needs to be stopped before injection of material, or the injectable material needs to have a very high viscosity in order not to be displaced.
A disadvantage of materials with a high viscosity is that these cannot be injected through thin catheters.
The set of additives in AneuFix / AneuFill provide these materials with a unique combination of a very high viscosity at rest (comparable to the consistency of peanut butter), and a low viscosity (comparable to olive oil) during injection. After injection the material recovers within seconds back to a high viscosity state, thus preventing any unwanted displacement.
As the siloxane polymer itself is insufficiently radiopaque, tantalum is added to AneuFix / AneuFill polymer to ensure good detectability during injection under x-ray. The tantalum particles used are predominantly in the sub-micron range, resulting in less scatter on CT scans at similar filling rates compared to competitive products using so-called micronized tantalum. Due to the composition of the siloxane polymer and form of the tantalum, no de-mixing or sagging-out occurs, and thus no shaking before use is required. Furthermore, the tantalum is perfectly dispersed in the polymer resulting in homogeneous radiopacity throughout the procedure